Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Regulated
Medical Waste

Regulated medical waste is defined by the Oklahoma
Department of Environmental Quality as a waste or reusable material
that contains an “etiologic agent” and is generated in the diagnosis,
treatment or immunization of human beings or animals; research pertaining
to the diagnosis, treatment or immunization of human beings or disabling
or fatal disease. The term “etiologic agent” is synonymous with the
term “infectious substance”. Examples of RMW include:

contaminated carcasses, body parts and bedding
of animals intentionally exposed to pathogens in research, in the
production of biologicals or the "in vivo" testing of pharmaceuticals;

items contaminated with blood or other human body
fluids which drip freely or would release such materials in a liquid
or semi-liquid state if compressed or are caked with dried blood
or body fluids and are capable of releasing these materials;

isolation wastes unless determined to be noninfectious
by the infection control committee at the health care facility;

HIV-containing cell or tissue cultures, organ
cultures, and HIV- or HBV-containing culture medium or other solutions;
and blood, organs, or other tissues from experimental animals infected
with HIV or HBV;

all disposable materials that have come in contact
with cytotoxic or antineoplastic agents during the preparation, handling,
and administration of such agents. Such wastes include, but are not
limited to, masks, gloves, gowns, empty IV tubing and bags, vials,
and other contaminated materials; and

any other material or equipment which, in the
determination of the health care facility staff, infection control
committee or other responsible party, presents a significant danger
of infection because it is contaminated with, or may reasonably be
expected to be contaminated with, etiologic agents.

Healthcare Facility RMW Regulations

Medical waste is regulated by several Oklahoma state
agencies. The applicable regulations of each agency are summarized
below. Links are provided to the full text regulations.

The
Oklahoma State Department of Health: Hospital Standards

The Oklahoma
State Department of Health hospital standards require that each
hospital establish an infection control program to provide a sanitary
environment and avoid sources and transmission of infections. The
program must include written policies and procedures for identifying,
reporting, evaluating and maintaining records of infections among
patients and personnel, for ongoing review and evaluation of all
aseptic, isolation and sanitation techniques employed in the hospital,
and development and coordination of training programs in infection
control for all hospital personnel. The standards also require that
the infection control program include specific policies related to
the handling and disposal of biomedical waste. However, no specific
guidance is provided. For more information, see Subchapter 11: Infection
Control in Hospital Standards
(Title 310. Oklahoma State Department of Chapter 667).

The same regulation also
covers design and construction requirements for hospitals (see Subchapter
49: General Medical Surgical Hospital Construction Requirements). Incinerators
are required for destruction of pathological waste, unless arrangements
are made with a licensed service to pick up the waste for disposal. Incinerators
may be shared by two or more nearby hospitals. Basic design standards
for incinerators are contained in the regulation.

Storage of Regulated Medical Waste. Healthcare
facilities are not subject to the storage requirements of Title
252 Chapter 515. However, OSHA storage requirements do apply to healthcare
facilities (see OSHA regulations below). Regulated medical waste processing
facilities must meet the following storage standards for RMW.

All waste must be processed or placed into refrigerated
storage, at 45 degrees F, within 24 hours of delivery.

If processing has not occurred within 96 hours,
waste shall be transported to an alternate permitted site.

Disposal of Regulated Medical Waste. The
disposal of the following RMW is prohibited in a municipal solid
waste landfill, a municipal solid waste receptacle or a municipal solid
waste transfer station:

Untreated sharps.

Other untreated, regulated medical waste, except
that generated by a small quantity regulated medical waste generator
(a generator that generates less than sixty (60) pounds of regulated
medical waste per month from one physical location).

Liquid regulated medical wastes (except chemical
wastes, or antineoplastic or cytotoxic drugs) may be discharged into
the collection system of a publicly owned treatment works (POTW) within
the generating facility if written approval of the POTW has been obtained
and the POTW provides secondary treatment.

Treatment of Regulated Medical Waste. Regulated
medical waste must not be compacted.

It must be treated by one of the following methods:

Incineration in an incinerator that is designed
for the destruction of regulated medical waste, will consistently
achieve microbial inactivation and is permitted by the DEQ’s Air
Quality Division and operated in accordance with the permit.

Microwave sterilization, or steam sterilization
at sufficient temperature and pressure, for sufficient time to consistently
achieve microbial inactivation.

Chemical disinfection where contact time, concentration
and quantity of the disinfectant are sufficient to consistently achieve
microbial inactivation.

Any other treatment method demonstrated to be
effective in consistently achieving microbial inactivation.

Occupational Safety and
Health (OSHA)

Oklahoma is one of 26 states covered entirely by
the federal OSHA program. OSHA rules impact several aspects of regulated
medical waste, including management of sharps, requirements for containers
that hold or store RMW, labeling of RMW bags/containers, and employee
training. These requirements can be found in the HERC OSHA Standards
for Regulated Waste section.